tbuckley/cabot-search huggingface dataset:
Clinical trial deserts: US urban vs rural patient enrollment among patients with advanced cancer in phase 1 clinical trials at a major cancer center.
Authors: Tara Marie Davidson, Hung Le, Erick Campbell, Cherri A. Ozenne, Ecaterina Elena Dumbrava, Siqing Fu, David S. Hong, Daniel D. Karp, Aung Naing, Sarina A. Piha-Paul, Jordi Rodon Ahnert, Apostolia Maria Tsimberidou, Timothy A. Yap, Funda Meric-Bernstam, Vivek Subbiah
Journal: Journal of Clinical Oncology (2023)

e18594 Background: Ethically and scientifically clinical trials must be equally accessible. Unfortunately, racial and ethnic minorities, socioeconomically disadvantaged, elderly and rural populations continue to be underrepresented in all phases of cancer clinical trials due to multiple interrelated economic, cultural, social and medical barriers. Per U.S. 2010 census data about 57 million people (18-19% of the population) and 84% of the U.S. land mass qualify as rural. Examining the affect of geographic distance from trial sites and rural residency on patient enrollment in early phase cancer trials will aid in prioritizing how to address these barriers. Methods: We reviewed EMR data from 8/1/2016 to 8/1/2022 on all initial visits of consults and new patients with advanced cancer ( &gt; 18 years of age) to a single institution phase 1 clinical trials unit. International patients and those without provided addresses were excluded. Bing geocode data for patient’s home zip codes was used in conjunction with the haversine distance formula to determine geographic distance to the cancer center. Rural-Urban Commuting Area codes, which classify U.S. 2010 census tracts based on zip codes using measures of population density, urbanization and daily commuting, were used to determine rural vs urban areas based on the Rural Health Research Center Categorization A and the Federal Office of Rural Health Policy definitions. Results: Among the 10,630 patients with diverse cancers referred to the phase 1 unit, 9182 patients (86.4%) were urban vs. 1448 (13.6%) rural. Patients from urban areas were more likely female 53.8% (4939) vs rural areas 49.2% (712). In terms of race, full data is provided in Table 1 with significantly less diversity in rural enrollment. Travel distance for study inclusion in urban vs rural patients was: 32.8% (3012) vs. 11.1% (161) &lt; 100 miles, 37.0% (3396) vs. 53.9% (781) 100-499 miles, 19.7% (1813) vs. 26.2% (379) 500-1000 miles and 10.5% (961) vs. 8.8% (127) &gt; 1000 miles. Overall, 75.6% (6944) patients from urban and 77.1% (1117) patients from rural areas consented to ≤ 1 study. Of those that consented 62.5% (4337) of urban patients and 64.0% (715) of rural patients enrolled in study. Conclusions: The largest Phase 1 cancer trial cohort of patients with advanced cancer with provided demographics and distance traveled for trial participation reveals disparities among U.S. rural vs. urban enrollment. Clearer understanding of these populations will allow for improved trial design and broad accrual. [Table: see text]
Oligo-residual disease in PD-1/PD-L1 inhibitor-treated metastatic non-small cell lung cancer: Incidence, pattern of failure and clinical value of local consolidative therapy.
Authors: Jinmeng Zhang, Jie Gao, Shanshan Jiang, Yue Zhou, Tiantian Guo, JianJiao Ni, Zhengfei Zhu, Zhen Zhang
Journal: Journal of Clinical Oncology (2023)

e21143 Background: Growing numbers of clinical trials are testing the efficacy of incorporating local therapy into programmed death receptor (ligand) 1 (PD-1/PD-L1) inhibitors in metastatic non-small cell lung cancer (NSCLC), but the optimal timing and patient selection are still controversial. We aimed to examine the patterns of maximum tumor response and treatment failure in PD-1/PD-L1 inhibitor-treated NSCLC, and explore the potential clinical value of local consolidative therapy (LCT) in those with oligo-residual disease (ORD). Methods: Metastatic NSCLC treated with PD-1/PD-L1 inhibitors in three academic centers from May 2018 to December 2021 were retrospectively reviewed and those derived clinical benefit, defined as having objective response or durable stable disease lasting≥6months, were finally enrolled. Patterns of tumor response and treatment failure were extensively analyzed. ORD was defined as residual tumor distribution limited to 3 organs and 5 lesions, otherwise was defined as multiple residual disease (MRD). Local therapies targeting the residual tumor lesions performed after PD-1/PD-L1 inhibitors initiation and before initial disease progression, were considered as LCT. The primary endpoints were the overall survival (OS) and progression-free survival (PFS). Results: Of the 318 patients enrolled, ORD and MRD were documented in 122 (38.4%) and 196 (61.6%) patients, respectively. Those who developed ORD had a significantly longer OS than those with MRD (p = 0.006). The median time to best response was 4 months and more than 50% of the initial disease progression developed only from the residual tumor lesions, providing the preliminary rationale of LCT. Among the 122 patients with ORD, those receiving LCT (n = 39) had significantly longer PFS (p = 0.04) and OS (p &lt; 0.001) than those without LCT. Moreover, LCT remained one of the independent predictors of improved PFS and OS after Cox analyses. Conclusions: Local consolidative therapy seems to be feasible and may provide extra survival benefit for metastatic NSCLC patients with oligo-residual disease after PD-1/PD-L1 inhibitor treatment.
Superior outcomes after allogeneic stem cell transplantation (SCT) among patients (Pts) ≥ 60 years (yrs) treated with cladribine (CLAD), low dose cytarabine (LDAC) plus venetoclax (Ven) for newly diagnosed acute myeloid leukemia (AML).
Authors: Jayastu Senapati, Hagop M. Kantarjian, Alexandre Bazinet, Patrick Kevin Reville, Gautam Borthakur, Naval Guastad Daver, Courtney Denton Dinardo, Alex Bataller, Elias Jabbour, Nicholas James Short, Uday R. Popat, Amin Majid Alousi, Elizabeth J. Shpall, Guillermo Garcia-Manero, Farhad Ravandi, Tapan M. Kadia
Journal: Journal of Clinical Oncology (2023)

7047 Background: CLAD/LDAC/VEN alternating with AZA-VEN has shown promising outcomes in older pts with AML ( Kadia, JCO Nov 2022). Improved disease control and preserved performance status achieved with CLAD/LDAC/VEN treatment, may translate into superior post-SCT outcomes. Methods: We compared outcomes of pts ≥ 60 yrs of age treated on the phase II study of CLAD-LDAC-VEN who underwent SCT in 1st remission (CR1) to a retrospective cohort of pts ≥ 60 yrs treated with hypomethylating agent (HMA)-VEN based or intensive (INT) therapy who underwent SCT in CR1 between 2013-2022. Relapse free survival (RFS) was from response to relapse/death &amp; overall survival (OS) from start of therapy to death. Results: 35 pts treated with CLAD-LDAC-VEN were compared to 42 pts treated with INT &amp; 40 pts with HMA-VEN therapy for remission induction prior to SCT at our center (Table). The median age of pts in the low-intensity arms were similar (68 yrs), but lower on the INT arm (62 yrs). More pts post INT therapy received a myeloablative conditioning (MAC). At a median follow up of 17+ months (m) for CLAD-LDAC-VEN arm, 59 m for INT arm, and 30 m for HMA arm, the median RFS (NR vs. 50 m vs. 20 m respectively, p &lt;0.01) and OS (NR vs. 58 m vs. 32 m respectively, p &lt; 0.01) was superior for the CLAD-LDAC-VEN arm. 3-yr cumulative incidence of relapse &amp; NRM (as competing events) were both significantly lower with CLAD-LDAC-VEN (4% and 7%) compared to INT (17% and 23%) or HMA-VEN (41% and 27%) therapy. Conclusions: Older pts with AML proceeding to SCT after CLAD-LDAC-VEN therapy had significantly improved survival, characterized by significantly lower rates of NRM and relapse compared to HMA-VEN or INT therapies. Larger studies and longer follow up is needed to confirm its benefit. [Table: see text]
Depression, systemic inflammation, and exposure to discrimination among sexual and gender minority (SGM) cancer survivors.
Authors: Charles Stewart Kamen, Daniel Curtis McFarland, Po-Ju Lin, Karen Michelle Mustian, Luke Joseph Peppone, Gary R. Morrow, Michelle Christine Janelsins
Journal: Journal of Clinical Oncology (2023)

6544 Background: Our prior research shows that SGM cancer survivors experience high rates of depression, due in part to exposure to discrimination. Depression among cancer survivors in general has been linked to markers of systemic inflammation including peripheral blood interleukin (IL)-6, tumor necrosis factor alpha (TNFα), and C-reactive protein (CRP). To date, no studies have examined the association of these markers with depression among SGM cancer survivors in the context of discrimination. Methods: Cross-sectional patient-reported data and serum samples were collected from 66 SGM cancer survivors (see Table). Depression was assessed by the Patient Health Questionnaire (PHQ)-9, discrimination by the Harassment, Rejection, and Discrimination Scale (HHRDS), IL6 and TNFα by multiplex assay, and CRP by ELISA. We used a clinical cut-point for depression of 10 on the PHQ-9, indicating moderate depressive symptoms, and assessed associations between continuous variables using bivariate correlations and multivariate linear regressions. Results: More SGM cancer survivors exceeded the clinical cut-point for depression (15.9%) than cancer survivors in prior general population samples (11.3%). Higher depression among SGM cancer survivors was associated with higher levels of exposure to discrimination (r=0.28, p=0.03), TNFα (r=0.30, p=0.02), and CRP (r=0.39, p=0.002); exposure to workplace discrimination, specifically, was associated with higher levels of CRP (r=0.32, p=0.02). In multivariate models controlling for demographic and clinical characteristics, CRP remained a significant predictor of depression (β=0.34, p=0.01). Conclusions: This study replicates prior findings of high levels of depression among SGM cancer survivors. It provides preliminary evidence that markers of inflammation, specifically CRP, are uniquely predictive of depression among SGM cancer survivors in the context of exposure to discrimination. These findings need to be replicated in larger samples and evaluated for potential use in providing supportive cancer care to SGM survivors. [Table: see text]
Clear cell chondrosarcoma: A national analysis exploring the demographic features.
Authors: Yanick Tade, Beau Hsia, Darby Keirns, Peter T. Silberstein, Xinxin Wu
Journal: Journal of Clinical Oncology (2023)

e23503 Background: Clear cell chondrosarcoma (CCCS) is an uncommon cancer and variant of chondrosarcoma affecting the proximal portion of long bones, commonly the femur or humerus. This low-grade and slowly progressing malignant tumor is often mistaken for benign tumors (i.e. chondroblastoma), but its histological features of benign giant cells and cells with clear cytoplasm alongside pathologic, roentgenographic, and clinical characteristics aid in its distinction. Accurate identification will guide the establishment of standard treatment algorithms and further improve treatment outcomes. CCCS has an overall 10-year survival rate of 89% with a median time to death from disease of 15.3 years. The National Cancer Database (NCDB) was analyzed to determine how patient demographic characteristics affect the diagnosis of CCCS. Methods: A retrospective cohort study from 2004 to 2020 was conducted using the NCDB. 188 patients were found with a histologically confirmed diagnosis of CCCS (ICD-9242-3). Gender, race, Hispanic origin, insurance coverage, type of treatment facility, and distance from patient residence to treatment facility were analyzed via descriptive statistics and trends in incidence were interpreted using regression analysis. Results: The frequency of patients diagnosed with CCCS has remained consistent since 2004 (R2 = 0.1) with over 11 diagnoses per year. Of the 188 patients found, the average age of diagnosis was 47.8 years (SD = 16.7, range = 14 – 90 years). Approximately two-thirds of patients were male (68.1%) and the remainder were female (31.9%). Most of the patients were White (84.6%). Patient Hispanic status could not be accurately determined due to limited data. More patients were in the top income quartile (31.9%) than those in the second (26.1%), third (19.7%), or fourth (12.2%) quartiles. The other 10.1% were of unknown income status. Most patients were privately insured (61.7%), followed by coverage under Medicare/Medicaid (27.1%). More patients lived in metropolitan counties with a population of 250,000 or more (85%) compared to less-populated urban or rural areas (15%). A large percentage of patients were treated at an academic/research program (61.6%) compared to non-academic programs (38.4%). Patients traveled an average of 65.8 miles (SD = 101.4, range = 0.8 – 793.0) to get to the treatment facility. Conclusions: CCCS remains a rare diagnosis. This study explores a significant gap in existing knowledge on patient characteristics that might present with CCCS. Most patients were White, insured by private insurance, in the top quartile of income earners, and lived in metropolitan areas. This novel study of socioeconomic factors in CCCS patients suggests that patients with higher socioeconomic status in highly-populated areas might have better access to this uncommon diagnosis. As such, additional research to comprehend the role that socioeconomic status might have on CCCS would be beneficial.
National overview of gastrointestinal stromal tumors: Experience from middle income setting.
Authors: Benik Mkhitaryan, Davit Zohrabyan, Liana Safaryan, Samvel Bardakhchyan, Armen Arzumanyan, Martin Harutyunyan, Armen Mkhitaryan, Amalya Sargsyan, Marine Rushanyan, Gohar Mkrtchyan, Mariam Mailyan, Nune Karapetyan
Journal: Journal of Clinical Oncology (2023)

e23515 Background: Gastrointestinal stromal tumors (GISTs) are mesenchymal malignancies representing 1-2% of all gastrointestinal cancers. There is a general shortage of reported data on GISTs from the Republic of Armenia (RA). This paper aims to conduct a national assessment of the epidemiological, diagnostic, and treatment approaches of the GISTs in RA. Methods: The study utilizes a cross-sectional design. Five-year retrospective data on patients with the moderate and high-risk group has been analyzed (from August 31, 2016, up to February 01, 2023). Data has been obtained through medical records. It was feasible to apply census sampling since each GIST patient receives Imatinib in the Hematology Center after prof. Yeolyan free of charge and all the medical records are centered in this facility. Descriptive analysis has been done to demonstrate patients’ demographic characteristics, the spread of the disease, pathological and genetic features of the tumor, and performed treatment. Results: In total 69 moderate and high-risk patients have been targeted. That counts for about 1% of all GI tumors diagnosed in Armenia in 2021. The mortality rate was 10%. The male-to-female ratio was 1.56:1. Age range was 30-81 years (median 58). Advanced disease was observed in 31.9% of cases. The primary site of the tumor (gastric vs non-gastric) was not significantly associated with the disease stage (p-value: 0.192). Expression of CD34, CD117, and DOG1 was positive in 97.3%, 100%, and 96.7% of cases respectively. However, it is worth mentioning that data on immunohistochemical (IHC) features are lacking due to the incompleteness of medical records and the absence of a joint e-health system in Armenia. Furthermore, significant under-testing of the tumor genetic profile was observed. Only 3 patients were tested for KiT mutation (positive in all cases) and no one for PDGFRA mutation. Under-testing is caused by the high cost of genetic profiling which is covered out-of-pocket in RA. All patients received first-line tyrosine kinase inhibitors (TKI). Adjuvant or palliative radiation therapy (RT) was not applied. The majority of patients (95%) underwent tumor resection for curative or palliative purposes. Conclusions: Demographic and epidemiological profile of GISTs in RA is similar to the reported international data. In contrast, the rate of advanced diseases is higher in RA, possibly due to diagnosis delays. [Table: see text]
Brain metastasis burden and management in small cell lung cancer: An analysis of 8705 patients.
Authors: Karolina Gaebe, Anders W. Erickson, Natasha B. Leighl, Kelvin K. Chan, Benjamin H. Lok, Sunit Das
Journal: Journal of Clinical Oncology (2023)

8596 Background: Patients with small cell lung cancer (SCLC) have historically been characterised by poor overall survival (OS) and high risk for intracranial metastatic disease (IMD), but large-scale real-world evidence on clinical presentation and treatment in this population is lacking. These patients traditionally receive whole brain radiation therapy (WBRT) for IMD, however, a recent systematic review has indicated that OS following stereotactic radiosurgery (SRS) may be non-inferior compared with WBRT. We aim to describe the clinical characteristics and outcomes of patients with SCLC and IMD in Ontario, Canada. Methods: We included all patients diagnosed with SCLC between April 2007 and March 2018 identified through a provincial health administrative database. Information on patient and treatment characteristics, incidence and time to IMD, and OS from time of SCLC diagnosis were collected and analyzed using R. Results: A total of 8705 patients were included. Median age was 68 years (range 18-103). Most patients presented with extensive disease (n = 5625) and were diagnosed after 2011 (n = 5768). Patients who received chemotherapy (n = 5563) had significantly longer OS than those who did not (median 10.64 vs 1.58 months (mo), hazard ratio (HR) 0.36, 95% confidence interval (CI) 0.34-0.37). 6662 patients received brain imaging at the time of primary diagnosis (CT: 5126, MRI: 1536), and 88% of patients surviving longer than 6 mo received more than one follow-up brain scan. 31% developed IMD (synchronous: 1175, asynchronous: 1511) with median intracranial progression-free survival of 5.65 mo. Median OS of patients with IMD was 9.76 mo, 29 and 1300 received SRS and WBRT as first treatment for their IMD, respectively. OS was in favour of SRS over WBRT (median 20.47 vs 8.74 mo, HR 0.57, 95% CI 0.39-0.84), which remained significant in multivariate analysis (p &lt; 0.001). Conclusions: OS for patients with SCLC remains poor, and many patients present with IMD. With careful selection, patients with SCLC may benefit from SRS treatment.
Real-world (RW) treatment (tx) patterns of patients (pts) with higher-risk myelodysplastic syndrome (MDS) in a US RWE database (COTA).
Authors: Rami S. Komrokji, Leyla Hernandez Donoso, Sejla Hodzic, Henry F Owusu, Kevin Nolan, Claire Nourry, Maria Diez-Campelo
Journal: Journal of Clinical Oncology (2023)

e19077 Background: Pts with higher-risk MDS have poor outcomes. To understand current tx patterns/identify unmet needs, the COTA database, using pt-level curated electronic health record (EHR) data from centers across the US, was analyzed. Methods: This was a retrospective, descriptive analysis of deidentified secondary data from the COTA MDS RWE database. Data were abstracted from EHRs using these criteria: inclusion of adults with IPSS-R intermediate (I)/high (H)/very high-risk (vHR) MDS on/after 1/1/2012, exclusion of pts with no diagnosis date/clinician notes or pts with concurrent malignancies. Follow-up was until the last recorded event (last visit/other cancer/death; data cutoff 06/2022). Results: Data from 640 pts were included in this analysis. See Table for baseline demographic data. Most pts with IR- (225/281, 80%) and HR-MDS (162/239, 68%) were treated at community centers; pts with vHR-MDS were equally treated at academic (59/120, 49%) and community centers (61/120, 51%). Genetic/molecular data were limited; among pts with data available, the most common genetic mutation was TP53 (75/215, 35%). Of 640 pts, 108 (17%) did not receive tx and 110 (17%) received allogeneic stem cell transplant (alloSCT). Of those given systemic tx, hypomethylating agents (HMAs) were the most common first-line tx (444/532, 83%). Venetoclax was given to 35/640 pts (5%; as first line: 10/532, 2%; as second line: 20/170, 12%; as third line: 4/66, 6%). Median time to start tx from diagnosis was 2.2, 1.1, and 0.9 mo for IR-, HR-, and vHR-MDS, respectively. Of 512 pts assessed for first-line tx with duration data, tx duration was 7.4, 5.4, and 4.2 mo for IR-, HR-, and vHR-MDS, respectively. In 340 pts—including pts who underwent alloSCT—with response data, pts with IR-, HR-, and vHR-MDS had RW response rates (any response) of 73%, 72%, and 58%, respectively. Median OS (mOS) from start of tx was 29.0, 20.3, and 11.9 mo for IR-, HR-, and vHR-MDS, respectively. mOS (from tx start) according to tx: alloSCT 31.4 mo, chemotherapy 19.1 mo, HMAs 23.1 mo, investigational 22.1 mo, venetoclax 10.1 mo, and others 23.8 mo. About 20% of pts transformed into acute myeloid leukemia, chronic myeloid leukemia, chronic myelomonocytic leukemia, or chronic lymphocytic leukemia. Conclusions: This RW study showed that available tx for pts with higher-risk MDS in the US is limited and remains a high unmet need. [Table: see text]
Factors associated with long-term gastrointestinal toxicity in colorectal cancer survivors in the women’s health initiatives (WHI) study.
Authors: Claire Han, Kerryn Reding, Matthew Kalady, Rachel Lynn Yung, Electra Paskett
Journal: Journal of Clinical Oncology (2023)

e24057 Background: Colorectal cancer (CRC) survivors often experience long-term symptom toxicity after cancer treatments. We described persistent gastrointestinal (GI) toxicity related to cancer and treatments in long-term CRC survivors and assessed the risk and life impact factors of GI toxicity. Methods: A cross-sectional study utilized data from the Women’s Health Initiative (WHI) Life and Longevity After Cancer (LILAC) study that recruited postmenopausal women. CRC survivors after cancer treatments were included (N = 413). Pearson correlations/A Chi-square test and multivariable linear regression models were used to identify risk and impact factors of GI toxicity. Results: 81% of CRC survivors experienced persistent GI toxicity. Bloating/gas was the most prevalent (54.2%) and severe, followed by constipation (34.1%), diarrhea (33.4%), and abdominal/pelvic pain (28.6%). Time since cancer diagnosis (&lt; 5 years), advanced cancer stage, low income, high psychological distress, poor dietary habits and physical activity, and impaired life impact measures (health-related quality of life, daily life interferences, and body image) were significantly associated with several GI toxicities. Fatigue and sleep disturbance were the most significantly associated with long-term GI toxicity (Table 1). Abdominal/pelvic pain significantly influenced life impact measures. Conclusions: GI toxicities are highly prevalent among CRC survivors, specifically in patients with high psychological distress. A better understanding of the long-term GI toxicity in CRC survivors and identifying those more vulnerable may inform future directions for managing CRC survivorship. An individualized, multifaceted intervention is warranted to consider psychosocial support, lifestyle intervention, and physical rehabilitation. [Table: see text]